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Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations

NCT04822246 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-12-06

No results posted yet for this study

Summary

The main objective of this RCT is to compare the efficacy of a powder/water jet prophylaxis device and conventional hand excavation in excavating root surface caries, with regard to restoration survival/success in older adults.

The secondary outcome of this RCT is to assess the participants' treatment preferences for the received treatment with regard to the procedures involved and in the invasiveness of the procedures carried out during the ART restoration.

Conditions

  • Dental Caries Extending Into Dentin
  • Root Caries

Interventions

PROCEDURE

Control: Hand instrumentation for caries excavation

An enamel hatchet will be used to create access to the carious lesion and then removal of soft carious tissue will be undertaken with excavators. Excavation will be stopped when some resistance to excavation will be felt and the cavity will be then conditioned with polyacrylic acid for 20 s, washed and dried with cotton pellets. A high-viscosity glass-ionomer cement will be used to restore the cavity. Moisture control will be achieved with the use of cotton wool rolls. A chair-side assistant will hand-mix the glass-ionomer according to manufacturers' instructions and it will be placed in the cavity using the "press-finger" technique whenever the type of cavity allows it. In the case of root restorations, a glove coated with petroleum jelly will be used similarly to the "press-finger" technique to better condense the material into the cavity. Excess material will be removed; the restoration will be coated with petroleum jelly. No local anaesthetic will be used to provide ART treatment.

PROCEDURE

Intervention 1: EMS Airflow device for caries excavation

An enamel hatchet will first be used to gain access into the cavity. Then the powder-water prophylaxis device will be used for the removal of soft carious tissue with the sodium bicarbonate powder-water jet. Excavation will be stopped when the colour of the lesion begins to darken and all the soft deposits are evacuated. The excavation will be done intermittently allowing sufficient time to check with hand instrument the surface hardness of the lesion. If the lesion is still soft excavation will be continued until the surface is hard suitable for restoring. The cavity will be then rinsed with copious water spray to evacuate all the powder-water material. The restoration procedure with a glass-ionomer cement will be done following the same procedures as in the control group.

PROCEDURE

Intervention 2: Hand excavation + EMS Airflow device for caries excavation

The participants allocated to this group will have the caries excavated as described for the control group. Then prior to filling the excavated cavity, the procedure of sodium bicarbonate powder-water jet irrigation as described for the intervention group #1 will be performed to condition the prepared excavated cavity. Then the restorative procedure will be completed with the restorative material and procedures as described for the previous groups.

Sponsors & Collaborators

  • Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822246 on ClinicalTrials.gov